Kornimate/medical-research-clean huggingface dataset:
br1010 in patients with essential hypertension patients who do not adequately respond to fimasartan/amlodipine combination

Conditions: Essential Hypertension

Summary: the objective of this clinical study is to evaluate the efficacy and safety by comparing the br1010 treatment group to the fimasartan/amlodipine treatment group at week 8 in patients with essential hypertension who do not adequately respond to fimasartan/amlodipine combination


Eligibility criteria:
inclusion criteria: 1.voluntarily provided a written consent to participate in this clinical study 2.19 years old or above koreans living in korea 3.patients with uncontrolled essential hypertension at screening time(visit 1) * use antihypertensive drugs:140 mmhg ≤ sitsbp \< 200 mmhg * naïve: 160 mmhg ≤ sitsbp \< 200 mmhg 4.patients with uncontrolled hypertension after fimasartan/amlodipine 30/5mg treatment for 4 weeks at randomization(visit 2) (selected arm:140 mmhg ≤ sitsbp \< 200 mmhg 5.able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion exclusion criteria: 1. difference of sisbp ≥ 20 mmhg and sidbp ≥ 10 mmhg in 3 blood pressure measurements in the selected reference arm at the screening visit 2. blood pressure results showing sitdbp ≥ 120 mmhg at screening and baseline visit(visit 1; both arm, visit 2: selected arm) 3. treatment compliance of fimasartan/amlodipine 30/5mg \< 70% 4. heart failure(new york heart association class 3 and 4), ischemic heart disease, peripheral vascular disease 5. percutaneous coronary artery within 6 months prior to study 6. clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator 7. patients who have history of severe cerebrovascular disease within 6 months prior to study 8. type i diabetes mellitus or uncontrolled type ii diabetes mellitus(hba1c \> 9% at screening visit 9. patients who have history of severe or malignant retinopathy within 6 months prior to study 10. pregnant or lactating women 11. planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods 12. patients taking other clinical trial drugs within 4 weeks from the time of visit for screening 13. patients who are judged unsuitable to participate in this study by investigator
improving resilience and quality of life of stroke patients

Conditions: Stroke Patient; Caregiver

Summary: this study aims to (1) test the effect of family system care and theme care action module on resilience, family function, self-efficacy, and quality of life for stroke patients and their families and caregivers; and (2) interview stroke survivors (experimental group) using a semi-structured questionnaire to achieve a mix of qualitative and quantitative methodologies.

a randomized control-group pretest-posttest design was adopted. we also used a semi-structured questionnaire to qualitatively interview stroke survivors. the national institute of health stroke scale (nihss), chronic disease self-efficacy scales, resilience scale, mcmaster family assessment device, and quality of life scale were used to test the intervention effects. further, complex scientific concepts will be used to analyze the transition experience of stroke survivors. expected outcomes: the family system care and theme care action module can improve family function, resilience, self-efficacy, and quality of life for stroke patients and their caregivers.

Eligibility criteria:
inclusion criteria: stroke patient: * those who can use language expression, over 20 years old. * within 1-6 months of new onset; (c) patients willing to participate. family caregivers * family members or relatives and friends over 20 years of age who provide the care recipients' personal needs, financial, psychological, emotional care, etc. exclusion criteria: * aphasia

Keywords: resilience family system nursing self-efficacy quality of life complexity science transition theory caregiver stroke.
an asthma mobile intervention to promote patient-reported outcomes in primary care

Conditions: Asthma

Summary: through this study, the investigators will adapt the asthmaxcel mobile app and evaluate the adapted intervention through a randomized controlled trial.

through this study, the investigators will use patient and provider feedback to adapt the asthmaxcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.

Eligibility criteria:
inclusion criteria: english-speaking individuals \>18 years with: 1. persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication 2. able to give informed consent 3. smartphone (ios or android) access exclusion criteria: 1. use of oral corticosteroids in the 2 weeks prior to the baseline visit 2. pregnancy 3. severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol 4. patients that previously received asthmaxcel

Keywords: informatics asthma
feasibility trial of cbt for depersonalisation in psychosis

Conditions: Psychotic Disorders; Depersonalization

Summary: this is a feasibility trial designed to test the feasibility and acceptability of a brief form (six sessions) of cognitive behavioural therapy (cbt) for depersonalisation/derealisation (dp/dr) in those individuals who also have a diagnosis of a psychotic disorder. participants will be randomised to receive either six sessions of cbt targeting dp/dr symptoms or to a treatment as usual control condition.

depersonalisation/derealisation (dp/dr) are distressing symptoms of having a sense of detachment and unreality about oneself (dp) or the external world (dr). cognitive behavioural therapy (cbt) has been found to be beneficial in treating patients with chronic dp/dr. cbt for dp/dr includes educating patients about these experiences so they have a better understanding and less fear; teaching ways of coping to help them manage the symptoms better; helping reduce the impact on their day to day functioning; and working together to find less distressing ways of interpreting these experiences. recent research has highlighted that dp/dr symptoms are common in people diagnosed with psychotic disorders, and when present are linked with more severe psychotic symptoms. however, there has been no previous study to ascertain if cbt to target dp/dr in psychosis would be effective. this study therefore aims to establish the feasibility of a brief cbt intervention for dp/dr in people diagnosed with a psychotic disorder. it is hoped that the cbt will reduce the distress associated with dp/dr experiences, with a possibility of reducing psychotic phenomena in addition. the investigators will seek to recruit adults aged 18-70 with a current psychotic symptoms as well as meeting threshold for dp/dr disorder. participants will be randomly assigned to receive six sessions of cbt or to a treatment as usual control. outcomes will be assessed at baseline and follow-up interview at 10 weeks.

Eligibility criteria:
inclusion criteria: * current experience of psychotic symptoms, * meeting threshold for dp/dr disorder (scores greater than 70 on cambridge depersonalization scale (cds)). exclusion criteria: * insufficient capacity to provide informed consent; * insufficient proficiency in english (spoken and written) to engage in cbt; * a primary diagnosis of intellectual disability, head injury, substance misuse or organic cause for psychosis; * those currently engaging in cbt or other psychotherapy.

Keywords: randomized controlled trial
hypoglycemia in hospitalized patients

Conditions: Diabetes; Hypoglycemia

Summary: patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at risk for losing the ability to develop symptoms that warn them that they are having a low blood sugar. there is almost no available information investigating how the inability to feel symptoms of a low blood sugar contributes to the risk of this happening when people with diabetes are hospitalized. the purpose of this study is to develop a symptom score model that will help to identify patients at risk for low blood sugars in the hospital and to examine what happens to patients who do experience a low blood sugar in the hospital.

patients who develop recurrent hypoglycemia are predisposed to developing hypoglycemia-associated autonomic failure (haaf, impaired awareness). there is almost no information investigating the contribution of haaf as a risk factor for hypoglycemia in hospitalized patients. our central aim is to develop a validated inpatient hypoglycemic symptom score model to examine haaf and its correlation with cognitive dysfunction, re-hospitalization rates, inpatient morbidity and mortality. this will be a prospective non-blinded study performed in a tertiary care center that will include non-critically insulin treated patients with type 1 and 2 diabetes. we will identify patients who have experienced moderate hypoglycemia (40-70 mg/dl) or severe hypoglycemia (\< 40 mg/dl) within the prior 24 hours by daily generated computerized reports. participants will be asked to complete a hypoglycemia symptom scores questionnaire and cognitive testing within 24-36 hours post event. participants will be contacted at 6 and 12 months following the index hospitalization to obtain information regarding recurrent episodes of hypoglycemia, need for re-hospitalization, and occurrence of any new diabetes related complications.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes * non-critically ill hospitalized surgical and medical patients * anticipated length of stay (los) \>3 days * anticipated life expectancy \> 1 year * mentally competent individuals exclusion criteria: * patients who are admitted for hypoglycemia or diabetic ketoacidosis * anticipated los \<3 days * mentally incompetent individuals defined as any patient with evidence of dementia or delirium recorded in their medical history or progress note * patients receiving total parenteral nutrition * treatment with high dose narcotic medications * patients who would not be able to follow up at 3 to 6 and 9-12 months by telephone call * patients with expected life expectancy \< 1 year

Keywords: type 1 diabetes type 2 diabetes hypoglycemia cognition disorders inpatient
the empowerment model towards type 2 diabetic adults to enhance vegetable intake in achieving glycemic control

Conditions: Glycemic Control for Diabetes Mellitus

Summary: life style changes, particularly in dietary patterns have contributed a great deal to the incidence and risks of type 2 diabetes. decreased intakes of vegetables and fruits replaced by pre processed food, added sugar and those of animal origin lead towards rapid increase of adult-onset-diabetes. in spite of the knowledge of the benefit of consuming vegetable and fruits, and people are well informed, they still need to be committed to perform a behavior and implement these intention. behavioral approach methods have demonstrated successful adherence in health education with life style changes. objective: to identify the impact of the empowerment model to enhance vegetable intake in type 2 diabetes mellitus adults in achieving glycemic control.


Eligibility criteria:
inclusion criteria: * fasting blood glucose ≥126 mg/dl * hba1c \>8% exclusion criteria: * those who have serious, unstable medical conditions, or related to metabolic disorders (i.e. thyroid diseases) * significant co-morbid illnesses such as liver disease, kidney disease, cancer, bowel diseases/ malfunction, pregnancy or nursing mothers.

Keywords: hba1c
oct-angiography as a pronostic marker for visual impairment in patients undergoing neurosurgery for compressive macroadenoma : a prospective study.

Conditions: Pituitary Adenoma

Summary: the aim of the study is to assess accurancy of oct angiography as a pronostic marker for patients undergoing neurosurgery for compressiver macroadenoma as compared with visual acuity, visual field and oct.


Eligibility criteria:
inclusion criteria: * pituitary compressive adenoma (for experimental group) * pituitary non compressive adenoma exclusion criteria: * retinian disease * amblyopia * parkinson disease * pregnant woman

Keywords: macroadenoma
ethaselen for the treatment of thioredoxin reductase high expression advanced non-small cell lung cancers

Conditions: Carcinoma, Non-small Cell Lung

Summary: thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell growth and induce apoptosis. in china, phase 1 clinical trials of ethaselen showed that 1200 mg dose ethaselen could be well tolerated, in pre-clinical study we found that, approximately 50% non-small cell lung cancers harbored high thioredoxin reductase expression(ihc result ++ or +++), phase 1a/b of ethaselen had finished in 2008, the result showed that 1200mg ethaselen per day was safety and tolerated by chinese malignant tumor patients.in pre-clinical research, our group found that, elevated of thioredoxin reductase activity was associated with the expression of thioredoxin reductase tested by immunohistochemistry, which means high expression of this enzyme may be a favourite predicted factor of ethaselen, the specific inhibitor of thioredoxin reductase.

this phase 1c study will include patients pathologic diagnosis advanced non-small cell lung cancer who had received more than two lines standard treatment, according to nccn non-small cell lung cancer guideline, there were no standard treatment scheme for these patients. approximately 40 patients will be included in the study, patients will received oral ethaselen dispersible tablet, 600 mg bid dose, primary endpoint of this study is 6 week disease control rate(dcr, cr+pr+sd), secondary endpoints include progression free survival(pfs), overall survival(os), quality of life(qol) and drug safety.

Eligibility criteria:
inclusion criteria: * advanced non-small cell lung cancer, stage iiib/iv who had received more than 2 standard treatment scheme * 18-75 years old, anticipate overall survival more than 3 months, ecog 0-2 * within 4 weeks, not receive chemotherapy, radiotherapy or surgery * hb≥90g/l； anc ≥1.5×109/l；plt ≥80×109/l * egfr/alk mutation negative * immunohistochemistry test of cancer tissue showed ++ or +++ of thioredoxin reductase * brain metastasis without symptoms exclusion criteria: * according to nccn non-small cell lung cancer guidelines (2014 v3), there were standard treatment scheme for the patients * pregnancy or breast-feeding women * any serious disease which could not be controled * urine protein≥++, or 24h urine protein\>1g * received any anti-cancer treatment within 4 weeks

Keywords: non-small cell lung cancer thioredoxin reductase
preemptive and preventive acetaminophen/ibuprofen fixed-dose combination after robot-assisted radical prostatectomy

Conditions: Postoperative Pain

Summary: this prospective, randomized, double-blinded study is designed to compare opioid-sparing effect of preemptive and preventive intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing robot-assisted radical prostatectomy (rarp). we hypothesize that preemptive administration of intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity than preventive administration in patients undergoing rarp.

adult patients undergoing elective robot-assisted radical prostatectomy are randomly allocated to receive preemptive administration of acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=77) or preventive administration (n=77). the preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia. the preventive administration group will receive same dosage of drug for same duration when surgical site closure starts.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective robot-assisted radical prostatectomy under general anesthesia * american society of anesthesiologists (asa) physical classification i-ii * consent to iv-patient controlled analgesia use * willingness and ability to sign an informed consent document exclusion criteria: * who do not understand or agree with our study * american society of anesthesiologists (asa) physical classification iii-iv * chronic usage of opioid analgesics * moderate to severe pain with other cause before surgery * allergies to anesthetic or analgesic medications used in this study * anticipated blood loss larger than 2 liters * need for intensive care after surgery * history of gastric ulcer or gastrointestinal bleeding * history of liver failure, renal failure or heart failure * current alcoholism * taking anti-coagulation drugs or history of coagulation disease * history of bronchial asthma * medical or psychological disease that can affect the treatment response * taking barbitutate or tricyclic antidepressant

Keywords: postoperative pain
protein and microrna markers for early detection of alzheimer's disease

Conditions: Mild Cognitive Impairment

Summary: blood will be harvested from three groups of people, normal control, patients with mild cognitive impairment (mci) and patients with alzheimer's disease (ad), 20 people per group. the blood samples will be used to determine the difference in the expression of micrornas and proteins. blood samples will be harvested again at 6-month interval from patients. the combination of the micrornas and proteins that have different expression patterns between normal control and patients with mci will be constructed in a kit to detect the difference. this kit will be used in another set of the three groups of people to determine its sensitivity and specificity in detecting patients with mci.

as discussed above, patients' blood samples will be tested by chip to test microrna expression and liquid chromatography-mass spectrometry to determine protein expression. the differences in microrna and protein expression among the three groups, especially between the control and mci, will be analyzed. this information will be used to construct a kit that can contain probes to detect a few micrornas or proteins. this kit will be used in another set of patients to check its sensitivity and specificity. the first set of patients will also be followed up every 6 months for up to 1.5 years. blood samples will be harvested during the follow-ups. the changes in micrornas and proteins will be correlated with the changes of cognition. this information will be used for constructing the kit as well.

Eligibility criteria:
inclusion criteria: * age-matched with patients with mci group exclusion criteria: * with cognitive dysfunction * with major cardiovascular diseases, especially stroke and brain transient ischemic attack * on steroid treatment * with major organ diseases
evaluation of peer-led everybody project

Conditions: Body Image; Eating Disorder Symptom

Summary: the second trial of the everybody project explored the efficacy of the inclusive body image intervention when delivered by college peer leaders. the peer-facilitated everybody project was compared to a video and expressive writing comparison intervention through one-month follow-up.

the initial trial of the everybody project established that professional leaders could deliver a universal, inclusive body image program for college students, with benefit above and beyond a waitlist control condition. the second trial of the everybody project aimed to further evaluate the intervention using a more disseminable facilitator model: trained college student peer leaders. it also utilized a more rigorous comparison condition, where peer leaders conducted the two-session everybody project program or a time-matched video and expressive writing intervention. college students within a university in the pacific northwest united states were invited to participate in programming (universal intervention target). quantitative assessment included a comparison of changes in eating disorder risk factor outcomes across randomization conditions at pre- and post-intervention and one-month follow-up. feasibility and acceptability explored the impact of the peer delivered program within universal college student audiences.

Eligibility criteria:
inclusion criteria: * current college student enrolled at institution where research was taking place exclusion criteria: * none
predictive factors for complete myoma resection during hysteroscopic myomectomy

Conditions: Uterine Fibroids; Uterine Myomas

Summary: the aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram. this tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy.

overall, 10% of all uterine myomas are submucosal. these myomas spread into the uterine cavity, lifting the endometrial mucosa, and are a common cause of abnormal uterine bleeding, dysmenorrhea, early miscarriage and they may be a cause of infertility. hysteroscopic myomectomy is the surgical procedure of choice for the treatment of submucosal myomas, because it is minimally invasive and has the advantage of preserving the integrity of the uterine wall. the characteristics of the myomas (size, number and location) enables the surgeon to choose the surgical approach that will provide the best outcome for the patient, and may predict the chances of a complete hysteroscopic resection of myomas in one procedure.

Eligibility criteria:
inclusion criteria: * patients with ultrasonographic diagnosis of uterine myomas exclusion criteria: * patients with previous incomplete hysteroscopic myoma resection; * patients undergoing additional surgical procedures performed by hysteroscopy (such as, resection of endometrial polyps); * patients undergoing associated non-hysteroscopic surgical procedures; * patients with severe cardiovascular disease, decompensated diabetes and severe hematologic disorders
bioequivalence of eye drops and spray administration of vigamox

Conditions: Cataract

Summary: the study compares the amounts of vigamox absorbed when administered as eye drops or in a spray form. both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. the hypothesis is that there will be no difference between the 2 modes of administration.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective cataract surgery exclusion criteria: * allergy to vigamox